MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00513730

Device Problems Break (1069); Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.Imdrf impact code f23 captures the reportable event of additional intervention performed to implant another stent.

Event Description

It was reported to boston scientific corporation on april 25, 2023, that an ultraflex esophageal distal release covered stent was implanted in the esophagus for the treatment of esophageal cancer during a stent placement procedure performed on (b)(6) 2023.During the procedure, an attempt was made to reposition the stent for better coverage of the neoplasm using forceps; however, during the reposition attempt, the stent wire broke.The stent was unable to be removed and the patient was kept under observation.On (b)(6) 2023, another ultraflex esophageal stent was implanted stent-in-stent inside the original stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation on april 25, 2023, that an ultraflex esophageal distal release covered stent was implanted in the esophagus for the treatment of an extensive esophageal neoplasm due to esophageal cancer during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous due to big tumor and was not dilated prior to stent placement.During the procedure, an attempt was made to reposition the stent for better coverage of the neoplasm using forceps; however, during the reposition attempt, the stent wire broke.The stent was unable to be removed and the physician is comfortable leaving the stent implanted inside the patient.The patient was kept under observation.On (b)(6) 2023, another ultraflex esophageal stent was implanted stent-in-stent inside the original stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.Imdrf impact code f23 captures the reportable event of additional intervention performed to implant another stent.Block h11: block b5 has been corrected.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16916826
• MDR Text Key: 315064565
• Report Number: 3005099803-2023-02506
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: 08714729716150
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2023
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0028176345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male